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Caroline SamainCS

Caroline Samain

DMPK/Bioanalysis Expert, ex-Pfizer, Genentech

€800/day
Toulouse, FR
15+ years

Average response time: 1 hour

About Caroline

Pharmacology Project Manager and Bioanalytical Expert with 20+ years of international experience (France, USA) in biologics drug development (antibodies, ADCs, bi-specifics, mRNAs and peptides) for oncology and immunology indications.
Deep hands-on expertise in PK/PD, immunogenicity (ADA/NAb), biomarker assay development and data interpretation across pre-clinical and clinical studies. Proven track record leading cross-functional teams and managing CRO/CDMO partnerships for IND-enabling studies and regulatory filing support.
Experienced in setting up and running project management frameworks (timelines, milestones, risk assessment, budget) in both large pharma (Genentech, Pfizer) and incubator/startup environments (TIBH/INRAE, EODOC).
Preparation of funding applications for bpifrance, ANR, and Horizon Europe calls, along with post-award project monitoring and reporting.
Currently seeking a new challenge, in France, in the US, or remotely to bring deep biotechnology expertise to an ambitious biotech, pharmaceutical or CRO team.
  • English

    Native or bilingual

  • French

    Native or bilingual

  • Spanish

    Conversational

Can work on-site
Toulouse (up to 50km), Paris (up to 50km), Montpellier (up to 50km), Bordeaux (up to 50km)

Experience

  • self
    Consultant
    BIOTECH
    July 2023 - Today (2 years and 11 months)
    Toulouse, France
    Independent DMPK and bioanalytical consultant supporting biotech, pharma and CRO organizations on PK/PD strategy, immunogenicity assessment, CRO oversight and IND-enabling study support. Available in France, the US, or remotely.
  • Toulouse White Biotechnology (TWB)
    Integrator
    July 2021 - July 2023 (2 years)
    Toulouse, France
    Led project management for TIBH, an industrial bioproduction integrator, overseeing a portfolio of 6 funded biologics projects including a Horizon Europe program across 5 countries. Served as in-house bioanalytical expert while driving stakeholder communication between biotechs, academic labs and CROs.
  • EODOC
    Director of Operations, Digital Health Industry
    January 2018 - March 2020 (2 years and 2 months)
    Toulouse, France
    EODOC is a telehealth company focusing on providing patients with medical video consultations. Patients can install EODOC app on their smartphone and instantly talk to a physician 7 days a week. As director of operations, I was in charge of the regulatory affairs and legal monitoring, physicians' recruitment, patient community management and customer support.

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Education

  • MS, Biochemical Engineering
    INSA Toulouse - Institut National des Sciences Appliquées de Toulouse
    2001
    MS, Biochemical Engineering

Skill set

Categories

  • Other